Affymax, Takeda Pharma Announces Voluntary Recall Of OMONTYS Injection

(RTTNews.com) - Affymax, Inc. ( AFFY ) and Takeda Pharmaceutical Co. Ltd. Sunday announced nationwide voluntarily recall of all lots of OMONTYS injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.

The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS.

Since its launch, more than 25 thousands patients have received OMONTYS in the postmarketing setting. To date, fatal reactions have been reported in approximately 0.02 percent of patients following the first dose of intravenous administration.

The reported serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal, have occurred within 30 minutes after such administration of OMONTYS.

There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session.

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